BIO 2025: Understanding the Nuances of Cell Therapy Projects
Cell therapies are distinct from other therapies, meaning that CDMOs shouldn’t take a cookie-cutter approach to these unique projects, notes Nirupama Pike from Catalent in this post-BIO 2025 interview.
“Cell therapies, or as many people call them, “living therapies” are quite distinct from proteins, small molecules, and monoclonal antibodies,” remarks Nirupama Pike, PhD, Global Head of Strategic Alliances for Cell Therapy at Catalent. As a result, companies that are seeking a partner to progress a cell therapy candidate have diverse manufacturing needs that can be based on the therapeutic indication, cell type, starting materials, and final dose, she notes.
For Catalent, it is important to approach these types of projects on an individual basis, working closely with innovators to understand the nuances of the project, Pike explains. Employing a partnership approach that is individualized, tailored, and also flexible ensures efficiency, no matter the size of the sponsor company, and empowers everyone involved to put the patient first, she notes.
When considering the significant growth that has been seen within the cell therapy sector, Pike points out that the therapeutic success — the fact that they are curative — has been a major contributor. “The second [growth] driver is technological advances that we are making for these therapies, which are making them more durable and persistent when administered, with less side effects,” she says.
A further driver for market growth is the fact that there are over 1000 clinical trials already underway for a variety of cell therapies, Pike continues (1). As many of these trials have progressed through the clinical phases, moving from Phase I to Phase II, it indicates that the therapies have strong safety profiles, she asserts.
However, access to these promising therapies is still limited, Pike stresses. “There are many reports that suggest that only about 20–25% of eligible patients are receiving these therapies (2,3),” she says. “There are several reasons for that: lack of standardization of manufacturing processes; variability in starting materials, even raw materials; diverse manufacturing platforms and technologies that are married to specific IPs [intellectual properties] that companies have; and also, slow advancements in the analytical space, which is very important from a regulatory perspective.”
“So, while we have seen many advancements in the manufacturing space, there still remains an urgent need for pre-simplification of the manufacturing process,” Pike specifies. “One specific area that we, as a cell therapy CDMO, are focusing on is helping our partners de-risk the manufacturing process and make it GMP [good manufacturing practice] compliant at an early stage.”
Click the video above to view the full interview
References
Alliance for Regenerative Medicine. Ongoing Clinical Trials by Phase and Region. Q4 2024 Data Report, February 2025.
Odstrcil, M.S.; Lee, C.J.; Sobieski, C.; Weisdorf, D.; Couriel, D. Access to CAR T-Cell Therapy: Focus on Diversity, Equity and Inclusion. Blood Rev. 2024, 63, 101136.
Kaltwasser, J. Many Challenges, Opportunities for CAR T-Cell Therapies in Lymphoma. Targeted Oncology, Sept. 30, 2022.
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